AYUSH may provide a fillip to Ayurvedic drug industry
- The Union AYUSH Ministry’s recent direction to State governments to constitute expert committees to grant licences for patented and proprietary Ayurvedic drugs is expected to provide a fillip to the industry in Kerala.
- No new licences had been issued for patented and proprietary Ayurvedic drugs in Kerala in the past five years because of the State government’s insistence on mandatory clinical trials. It was one of the reasons for the closure of a good number of small manufacturing units. The government, however, lifted the provision on January 16, saying pilot studies supervised by an expert committee would be enough for granting licences.
- The expert panels, consisting of the seniormost Ayurveda officer in the office of the State Licensing Authority or Director, AYUSH; an expert on ‘dravyaguna’; an expert on Ayurvedic pharmacy or ‘rasashasthra’; and an Ayurvedic drug inspector, would streamline the licensing process.
- They will have to examine the licence application and associated documents, proof of concept and testing protocols of the intended patent or proprietary drug as provided in Section 3 (h) (i) of the Drugs and Cosmetics Act, 1940, and the Rules under it. They need to verify the reference of the proposed drug and its ingredients from authoritative books and ascertain that the excipients used in the formulation are in accordance with the provisions of the Rule 169 of the Drugs and Cosmetics Rules, 1945.
